Merck & Co. received FDA approval for Welireg (belzutifan) combined with Keytruda (pembrolizumab) as adjuvant treatment for adults with intermediate-high or high-risk clear cell renal cell carcinoma following kidney removal surgery. The approval, dated June 12, marks the first FDA nod for a PD-1 plus HIF-2α inhibitor combination in the adjuvant setting. The decision is anchored in the Litespark-022 pivotal study, where Welireg and Keytruda reduced the risk of disease recurrence, metastasis, or death by 28% versus Keytruda plus placebo across 1,841 patients. Estimated disease-free survival was 81% in the combo arm versus 74% with placebo, with overall survival results still not fully mature. Clinicians and payers will look closely at how this regimen fits into post-nephrectomy standard-of-care sequencing, especially as adjuvant strategies expand for high-risk patients. Merck’s approval also strengthens the company’s post-Keytruda runway as earlier-stage renal cell carcinoma becomes a focal growth area.